BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2

    K Number: K873011 · Decision Oct 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    82
    Applicant Total
    8
    Review Days
    86

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    Basic Information

    Device Name
    QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
    K Number
    K873011
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    August 4, 1987
    Decision Date
    October 29, 1987
    Product Code
    LAS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LAS Drug Specific Control Materials

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